GUEST COLUMNISTS

• Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring

  Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.

• Let's Stop Treating Allogeneic Cell Therapy As One Thing

  Industry is beginning to accept that allogeneic cell therapy spans categories, and success depends on aligning biology, regulation, and economics unique to each product.

• Allogeneic Cell Therapy Is Still Learning What Biology Will Allow

  Allogeneic cell therapy is advancing through smarter donor selection and manufacturing control, showing how biology, process design, and product consistency drive success.

• Building CGT Manufacturing Capacity For The Next Commercial Era

  Recent investments — mostly by CDMOs — are expanding manufacturing capacity to support the growing cell and gene therapy pipeline. We also discuss associated trends and impacts.

• Top 5 Challenges In Antibody-Oligonucleotide Manufacturing

  AOC manufacturing breaks programs in five predictable ways. Learn where antibody-oligonucleotide conjugate development stalls, from synthesis impurities to conjugation chemistry, and what preparation actually looks like.

• Managing The Presence Of Visible Particulates In Cell Therapies

  Here's a holistic approach to developing a comprehensive particulate control strategy for cell therapies, focusing on particle characterization, detection, and manufacturing controls. 

• Analyzing And Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis

  Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.

• Achieving Annex 1 Compliance In Sterile Manufacturing, Part 3: Building A Compliant Program

  In this third and final article of this series, let's take a closer look at what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance.